| Device Type ID | 3377 |
| Device Name | Kit, Screening, Urine |
| Regulation Description | Microorganism Differentiation And Identification Device. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.2660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JXA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3377 |
| Device | Kit, Screening, Urine |
| Product Code | JXA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Microorganism Differentiation And Identification Device. |
| CFR Regulation Number | 866.2660 [🔎] |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 17 |
False Negative Result | 4 |
Contamination During Use | 3 |
Incorrect Or Inadequate Test Results | 1 |
Output Problem | 1 |
Device Markings / Labelling Problem | 1 |
| Total Device Problems | 27 |